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RECRUITING
NCT07401836
NA

Standardized Sleep Bundle for Cardiac Surgery Patients

Sponsor: Horizon Health Network

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the feasibility of using a standardized sleep bundle in adults undergoing cardiac surgery. The main questions it aims to answer are: 1. Can eligible participants be recruited and retained in the study? 2. Can participants follow the study procedures, including using sleep aids and completing daily assessments? 3. Can sleep and other clinical data be reliably collected during the hospital stay? Researchers will compare participants who receive the sleep bundle to participants who receive usual postoperative care. Participants will: * Use non-drug sleep aids, including a sleep mask, ear plugs, and a noise machine (sleep bundle group only). * Take sleep medications if needed, following a stepwise protocol (sleep bundle group only). * Complete daily sleep assessments using the Richards-Campbell Sleep Questionnaire (RCSQ). * Wear a Fitbit device at night to track sleep. * Follow usual postoperative care routines (control group) The study will also collect and describe data on sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay to inform the design of a future larger trial.

Official title: Can a Standardized Sleep Bundle Reduce Sleep Disruption After Cardiac Surgery: A Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-03-02

Completion Date

2026-06

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

OTHER

Standardized Sleep Protocol

Non-Pharmacological Sleep Aids * All participants will be encouraged to wear a sleep mask and ear plugs nightly. In addition, a noise machine will be provided each night, the content and volume of which will be decided by the patient. * Stepwise Pharmacotherapy Approach Step 1: Melatonin \- Melatonin 6 mg orally at bedtime will be initiated for all participants in the sleep bundle group. Step 2: Adjunctive Therapy (Trazodone) * If the participants daily RCSQ score is below 63.4 or the participant reports inadequate sleep despite melatonin, trazodone will be scheduled orally at bedtime. * Trazodone will start at 25 mg and may be increased in 25 mg increments up to 100 mg orally at bedtime, based on participant response and tolerability. Step 3: Escalation for Delirium (Quetiapine) * If the participant has documented postoperative delirium, quetiapine 12.5 mg immediate release oral tablet will be scheduled at bedtime. * Dose may be increased in 12.5 mg increments up to 100 mg as cli

OTHER

Usual Post Operative Care

Standard postoperative care without the structured sleep bundle. This includes routine clinical management of sleep without non-pharmacological interventions or protocolized pharmacological sleep aid. Any sleep medications administered will be at the discretion of the care team, without a standardized approach, reflecting standard practice.

Locations (1)

Saint John Regional Hospital

Saint John, New Brunswick, Canada